Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

Summary

This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.

Timeline

Start

2021-03-17

Primary completion

2024-03-18

Completion

2024-04-22

Outcome

Missed primary endpoint

registry Point estimate -0.015 (95% CI -0.080 to 0.029) NCT04722991 ↗

Drugs

Indications